Drugs

Biosimilar Product Information

The Food and Drug Administration approves biosimilar products and provides the scientific and regulatory advice needed to bring safe and effective biosimilars to market. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

FDA-Approved Biosimilar Products

Drug Name

Approval Date

More Information

Udenyca
(pegfilgrastim-cbqv) 
November 2018 Udenyca Information 

Hyrimoz
(adalimumab-adaz)

October  2018

Hyrimoz Information

Nivestym
(filgrastim-aafi)

July 2018

Nivestym Information

Fulphila
(pegfilgrastim-jmdb)

June 2018

Fulphila Information
Press Release: FDA approves first biosimilar to Neulasta to help reduce the risk   of infection during cancer treatment

Retacrit
(epoetin alfa-epbx)

May 2018

Retacrit information
Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia

Ixifi
(infliximab-qbtx)

December 2017 

Ixifi information

Ogivri
(trastuzumab-dkst)

December 2017 

Ogivri information
Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers

Mvasi
(bevacizumab-awwb)

September 2017

Mvasi information
Press Release: FDA approves first biosimilar for the treatment of cancer

Cyltezo
(adalimumab-adbm)

August 2017

Cyltezo information  

Renflexis
(infliximab-abda)

May 2017

Renflexis information

Amjevita
(adalimumab -atto)

September 2016

Amjevita information
Press Release: FDA approves Amjevita


Erelzi
(etanercept-szzs)

August  2016

Erelzi information
Press Release: FDA approves Erelzi

Inflectra
(infliximab-dyyb)

April 2016

 

Inflectra information
Press Release: FDA approves Inflectra

Zarxio
(filgrastim-sndz)

March 2015

Zarxio information
Press Release: FDA approves first biosimilar

Learn More

Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act.

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Page Last Updated: 11/05/2018
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